Mandate of the Pharmacovigilance Risk Assessment Committee

Transkript

1 PRAC erfarenhet sedan juli 2012 (PRAC = Pharmacovigilance Risk Assessment Committee) Qun-Ying Yue, Senior Expert Enheten för Effekt och Säkerhet 1; LVs Farmakovigilansdag, 19 juni, 2015 Mandate of the Pharmacovigilance Risk Assessment Committee All aspects of the risk management of the use of medicinal products including the detection, assessment, minimisation and communication relating to the risk of adverse reactions, having due regard to the therapeutic effect of the medicinal product, the design and evaluation of post-authorisation safety studies and pharmacovigilance audit information som fanns tillgänglig vid presentationstillfället 1

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3 PRAC erfarenhet sedan juli 2012 Vad har PRAC levererat? Vad som är pågående? Hur ser PRAC s arbete ut framöver? EU PhV legislation 3 main themes Strengthened Vigilance Transparency and engagement Efficiency and simplification information som fanns tillgänglig vid presentationstillfället 3

4 There are now: Clear legal framework for post-authorisation safety monitoring with patient & public involvement Good Vigilance Practice guidance Timely review of new safety issues Risk management plans for all new medicines Post-authorisation studies - regulatory oversight Greater transparency First 2.5 years PRAC s main goals Proactively investigating drug safety - PASS, signal detection - wider definition of ADR Responding to safety & B/R issues risk-proportionate decisions to rigorous timescales, effectiveness of RM Transparency - real time access to info on PRAC activities Involvement of stakeholders - HCP, patients and public information som fanns tillgänglig vid presentationstillfället 4

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7 Ex. Fentanyl transdermal patch accidental exposure Signal Nov 2013, triggered by FDA in Sept 2013 Reason: improper handling, role of visibility Fatal cases in children PRAC recommendation: 1. Strengthened wording SmPC and PL 2. DHPC - fatal outcomes especially in children. 3. educational material, improve patch visibility 13 Signal detection ongoing focus PRAC s Signal Management Review Team meets monthly (SMART) Info to MAHs in advance of Agenda where possible Co-ordination of product information updates information som fanns tillgänglig vid presentationstillfället 7

8 Risk Management Plans 2012/ /14 Total Initial app Type II var PSUR Renewal Stand alone RMP- Reflections New RMP requirements cause increased number of documents For new generics without risk management beyond routine: an adm burden with no added value? Summary for the public in lay language: Value for the public? Effectiveness of additional risk minimisation measures eg DHPC, educational material Workload / burden Risk management plans - ongoing focus Revision of GVP V now underway Template simplification PRAC working with CMDh to facilitate drafting of RMPs for nationally authorised products 16 information som fanns tillgänglig vid presentationstillfället 8

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10 Art 20 Art 31 Urgent (art 107i) Tredaptive Almitrine RAS agents Codeine x2 Bromocriptine Trevaclyn Diclofenac Ambroxol/bro Pelzont HES mhexine Kogenate/ SABAs Hydroxyzine Helixate CHCs Ibuprofen and dexibuprofen Protelos/ Osseor Nicotinic acid Inhaled Ivabradine Diacerein corticosteroids Tysabri Zolpidem Domperidone Referrals - ongoing focus Procedural optimisation, eg Preparatory phase Best evidence consultation of relevant SAG, PCWP Interactions with MAHs Referrals involving established medicines Tetrazepam Cyproterone EE Flupirtine Numeta HES Methadone Periodic Safety Update Reports Shift to PSUR as important tool for reviewing B/R Proportion of outcomes involve updating product information, mostly 4.4 and 4.8 PRAC s evolving experience with single PSUR assessment information som fanns tillgänglig vid presentationstillfället 10

11 PRAC PSUR Outcome- Dec Dec PSUR PRAC recommendation from Dec 2012 Dec % to vary MA (Mainly changes to section 4.4 and 4.8 of the SmPC) No suspensions, no revocations PRAC PSUR Outcome- Dec Dec PSUR PRAC recommendation from Dec 2012 Dec 2014: 882 single CAPs PSURs 51 mixed CAPs and NAPs single assessments (PSUSAs) (5.5 % of all PSUR procedures) Presentat on title (to edit, click Insert > Header & Foo information som fanns tillgänglig vid presentationstillfället 11

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13 PRAC s work moving forward Workload and efficiency - single PSUR, generic RMPs Strengthening science for PRAC decisions GVP on biologics, effectiveness of risk minimisation, medication error Building stakeholder engagement expanding monthly communications, industry platform Involving Patients and HCPs - Public hearings to be introduced later in 2015 information som fanns tillgänglig vid presentationstillfället 13